Koshi Blerina, Grapci Arlinda Daka, Nebija Dashnor, Selmani Pranvera Breznica, Morina Rina, Crcarevska Maja Simonoska, Dodov Marija Glavas, Raichki Renata Slaveska
Department of Pharmacy, Faculty of Medicine, University of Prishtina "Hasan Prishtina", Prishtina, Republic of Kosovo.
Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Skopje "St. Cyril and Methodius", Skopje, Republic of North Macedonia.
Turk J Pediatr. 2022;64(1):49-58. doi: 10.24953/turkjped.2021.4136.
Medicinal products contain excipients that might be associated with toxicity in neonates. The aim of this study was to investigate the administration of medication containing potentially harmful excipients to neonates hospitalized in Kosovo and to identify the possibility of reducing neonatal exposure to these excipients through product substitution.
Data on all medication administered to hospitalized neonates from 1st of February to 1st of August 2018 along with patients` demographic data were collected from medical records for each neonate. Excipients were identified from the Summaries of Product Characteristics. Three stage criteria for product substitution were: (1) same active pharmaceutical ingredient (API) and route of administration; (2) 1 plus same dosage form; (3) 1 and 2 plus same strength.
In total, 100 excipients were found in 2388 prescriptions comprising 67 medications and 60 API administered to 294 (183 preterm and 111 term) hospitalized neonates. The excipients of interest (EOI) were present in 409 (17.1%) prescriptions and were administered to 131 (71.6%) preterm and 52 (46.8%) term neonates through a relatively small number of products (n=27; 32.8%). In relation to prescription frequency, the most common EOI was polysorbate 80, found in 229 (56%) of EOI-containing prescriptions. Substitution with EOIfree products was possible for 14 (63.6%), 12 (54.5%) and 5 (22.7%) products, according to the first-, second- and third-stage criteria, respectively.
We have provided the first detailed description of neonatal exposure to potentially harmful excipients among neonates admitted to a neonatal intensive care unit in Kosovo. Unnecessary exposure could be reduced by using EOI-free products available in the local medicine market. Collaborative initiative is required to build up the evidence on the use of EOI in neonates and raising awareness among health care professionals on use of products without EOI where possible.
药品中含有的辅料可能与新生儿毒性有关。本研究的目的是调查科索沃住院新生儿使用含有潜在有害辅料的药物情况，并确定通过产品替代减少新生儿接触这些辅料的可能性。
收集2018年2月1日至8月1日期间所有住院新生儿的用药数据以及患者的人口统计学数据，这些数据来自每个新生儿的病历。从产品特性摘要中识别辅料。产品替代的三阶段标准为：（1）相同的活性药物成分（API）和给药途径；（2）加上相同的剂型；（3）加上相同的规格。
在给294名（183名早产儿和111名足月儿）住院新生儿使用的2388张处方中，共发现了100种辅料，这些处方涉及67种药物和60种API。感兴趣的辅料（EOI）存在于409张（17.1%）处方中，通过相对较少的产品（n = 27；32.8%）给予了131名（71.6%）早产儿和52名（46.8%）足月儿。就处方频率而言，最常见的EOI是聚山梨醇酯80，在229张（56%）含EOI的处方中发现。根据第一、第二和第三阶段标准，分别有14种（63.6%）、12种（54.5%）和5种（22.7%）产品可以用不含EOI的产品替代。
我们首次详细描述了科索沃新生儿重症监护病房收治的新生儿接触潜在有害辅料的情况。通过使用当地药品市场上不含EOI的产品，可以减少不必要的接触。需要开展合作倡议，以积累关于新生儿使用EOI的证据，并提高医护人员对尽可能使用不含EOI产品的认识。
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